MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-11-21 for DEPEND WOMEN LARGE MAXIMUM manufactured by Kimberly-clark Corporation - Cold Springs.
[128019463]
A manufacturer lot code was not provided. With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and records can be performed. Complaints which are serious in nature are reviewed on a regular basis or for due cause to provide visibility and escalation. In addition, complaints are also monitored for trending on a monthly cadence. No further information is available at this time.
Patient Sequence No: 1, Text Type: N, H10
[128019465]
Consumer reported that her foot got caught in product while putting it on. She then slipped and dislocated her left shoulder and had 2 compression fractures in her spine. She was then taken by ambulance to the hospital and admitted on (b)(6) 2017 when shoulder surgery was performed. Since (b)(6) 2017, she has had multiple hospital visits. She was treated with morphine for pain. She continues to have pain and is going to chiropractor and physical therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184163-2018-00004 |
| MDR Report Key | 8094063 |
| Report Source | CONSUMER |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-21 |
| Date of Event | 2017-05-17 |
| Date Mfgr Received | 2018-10-29 |
| Date Added to Maude | 2018-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. MARIAN VARGAS |
| Manufacturer Street | 2100 WINCHESTER ROAD |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207215889 |
| Manufacturer G1 | KIMBERLY-CLARK CORPORATION - COLD SPRINGS |
| Manufacturer Street | 1050 COLD SPRINGS RD. |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 54956 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEPEND |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2018-11-21 |
| Model Number | WOMEN LARGE MAXIMUM |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK CORPORATION - COLD SPRINGS |
| Manufacturer Address | 1050 COLD SPRINGS RD. NEENAH WI 54956 US 54956 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-11-21 |